Thoratec

BACKGROUND: The use of continuous flow left ventricular assist devices (CF-LVAD) to treat advanced heart failure is increasing. While risk score such as MELD and the HeartMate II Risk Score require the use of INR, many patients are on anticoagulation prior to CF-LVAD implantation. The aim of this study was to evaluate the ability of the Model of End-Stage Liver Disease-eXcluding INR (MELD-XI) scoring system to predict clinical outcomes in patients with advanced heart failure who undergo CF-LVAD implantation...

Evaluation of left ventricular devices is becoming increasingly important as the implantation of these devices increases. Cardiac computed tomography angiography (CCTA) has many potential advantages compared with plain radiographs and echocardiography to troubleshoot these devices and potentially help guide therapy. Heart failure (HF) remains a deadly, progressive disease with substantive and increasing morbidity, mortality, cost, and prevalence. Use of left ventricular assist devices (LVAD) as treatment for refractory HF has been steadily rising during the last decade...

INTRODUCTION: Ventricular Assist Devices (VADs) are increasingly utilised in children with end-stage heart failure, and experience high bleeding and clotting rates. In particular, pediatric VAD patients are more challenging than adults to anticoagulate due to developmental hemostasis, lack of suitable drug preparations, and difficult anticoagulation monitoring often due to poor vascular access; in addition to difficulties of VAD design in smaller children. This review aims to summarize the current evidence related to antithrombotic therapy in pediatric VAD patients...

A novel sternotomy sparing implantation technique for the Thoratec HeartMate 3 is described. Cannulation of the left ventricular apex is performed via a minithoracotomy in the left fourth or fifth intercostal space. The outflow graft is advanced through the pericardium to a second minithoracotomy in the right second intercostal space and then anastomosed to the ascending aorta. This approach was performed in three patients so far with no need for conversion. We did not observe any perioperative adverse events, such as bleeding or thromboembolic complications, as well as no short-term mortality...

BACKGROUND: Having a preoperative small left ventricle (LV) has been associated with higher complication and mortality rates after left ventricular assist device (LVAD) implantation; however, the outcomes after continuous-flow LVAD implantation have not been well studied. This is the first large-scale analysis of long-term survival after continuous-flow LVAD implantation in patients with a preoperative small LV. METHODS: Our cohort comprised 511 patients who underwent primary implantation of a HeartMate II (n = 393 [Thoratec, Pleasanton, CA]) or HeartWare HVAD (n = 118 [HeartWare International, Framingham, MA]) at our institution between November 2003 and March 2016...

BACKGROUND: Thrombosis within a left ventricular assist device (LVAD) is a devastating complication that often necessitates device exchange. Few studies have evaluated the relationship between patient anatomy and pump thrombosis. We hypothesize that lateral displacement of the left ventricular (LV) apex increases risk for pump thrombosis. METHODS: All patients who underwent primary implantation of a HeartMate II (HM2) device (Thoratec, Pleasanton, CA) at a single center (2009-2015) were evaluated...

Driveline or device infection may complicate left ventricular assist device implants, and only curative option may be pump exchange. Replacement with similar device may be liable to reinfection, because pump configuration is such that the new device and driveline may partly lie within the pocket of the previous pump. One approach to overcome this is using a different pump design such that the new pump would lie in a different location from the old pump. We describe treatment of severe HeartMate II (Abbott, [St Jude Thoratec Corp], Pleasanton, CA USA) left ventricular assist device infection by minimally invasive exchange to an intrapericardial HVAD (HeartWare International, Inc, Framingham, MA USA) left ventricular assist device...

BACKGROUND: This study examines our institutional ventricular assist devices (VADs) experience over two decades to understand trends towards predictors of mortality. METHODS: Retrospective study of patients aged 0-21years supported with a VAD from January 1996 to May 2015. Patient data was examined pre and post-VAD implant among survivors and non-survivors. RESULTS: Thirty-six patients identified (8 supported by Thoratec® VAD and 28 supported by EXCOR Berlin Heart®)...

BACKGROUND: Optimal anticoagulation strategy remains uncertain in patients with heparin-induced thrombocytopenia (HIT) and undergoing left ventricular assist device (LVAD) implantation. We describe our protocol of abciximab and heparin in these patients. METHODS: Our protocol is to administer abciximab, 0.25 mg/kg loading dose, followed by continuous infusion of 0.125 μg · kg-1 · min-1 throughout cardiopulmonary bypass. Full-dose heparin is then given with subsequent additional doses to maintain an activated clotting time of 400 seconds or longer...

This study aimed to compare von Willebrand factor (vWF) levels, ristocetin cofactor levels, platelet counts, aortic valve movements, and right heart failure (RHF) as risk factors of gastrointestinal (GI) bleeding in patients with continuous flow left ventricular assist device (cf-LVAD). In a single centre, 90 patients (mean age 52.0 ± 10.5 years), of which 59 were male and 31 were female, had cf-LVAD implantation from October 2010 to November 2012. Seventy-six (84.4%) patients had HeartWare (Medtronic, Mounds View, MN) and 14 (15...

Patients with Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) levels 1-2 who either have or are at risk for right ventricular failure face significant morbidity and mortality after continuous flow left ventricular assist device (CF-LVAD) implantation. Currently, the options for biventricular support are limited the Total Artificial Heart (TAH; CardioWest, Syncardia, Tuscon, AZ) or biventricular assist device (BiVAD), which uses bulky extracorporeal or implantable displacement pumps...

CorMatrix is an organic extracellular matrix (ECM) derived from porcine small intestine submucosa and is used for pericardial closure and cardiac tissue repair. During explantation of a HeartMate II (Thoratec Corp, Pleasanton, CA) left ventricular assist device (LVAD) because of infection, CorMatrix was used to repair the left ventricular apex and aorta. Three months later, a HeartWare HVAD (HeartWare International, Inc, Framingham, MA) was implanted for recurrent heart failure. Excised apical CorMatrix samples showed cardiac tissue remodeling with viable cardiomyoblasts similar to native myocardium...

BACKGROUND: The HeartMate II (St. Jude Medical, Inc, St. Paul, MN [previously Thoratec]) left ventricular assist device (LVAD) exchange has traditionally involved a redo sternotomy. Alternate minimally invasive subcostal approaches have the advantage of avoiding sternal reentry, excessive bleeding, and prolonged recovery. METHODS: This retrospective review included patients who underwent an exchange from May 2009 to March 2016. The patients were divided into three cohorts: (1) redo sternotomy, (2) subcostal approach involving cardiopulmonary bypass (CPB) (ON-CPB SC), and (3) subcostal approach off the CPB pump (OFF-CPB SC)...

BACKGROUND: Optimal timing of heart transplantation in patients supported with second-generation left ventricular assist devices (LVADs) is unknown. Despite this, patients with LVADs continue to receive priority on the heart transplant waiting list. Our objective was to determine the optimal timing of transplantation for patients bridged with continuous-flow LVADs. METHODS: A total of 301 HeartMate II LVADs (Thoratec Corp, Pleasanton, CA) were implanted in 285 patients from October 2004 to June 2013, and 86 patients underwent transplantation through the end of follow-up...

OBJECTIVE: To determine whether the ratio of peak systolic-to-nadir diastolic velocity (S/D ratio) measured using Doppler at the left ventricular assist device (LVAD) inflow and outflow cannulae is associated with pump thrombosis and to determine whether there is an absolute decrease in the diastolic cannula velocities in LVAD thrombosis. DESIGN: Retrospective chart review. SETTING: University hospital. PARTICIPANTS: Patients who underwent LVAD exchange...

BACKGROUND: There are minimal circulatory support options for patients with a failing Fontan. The Heartmate II (HMII) left ventricular assist device (Thoratec, Bedford, MA) in its packaged state cannot augment caval/pulmonary arterial blood flow. AIM: We hypothesized that a modified HMII pump could augment caval and pulmonary arterial blood flow. METHODS: A bifurcated ringed Gore-Tex graft (W. L. Gore & Associates, Flagstaff, AZ) was sewn to the HMII inflow, and the outflow graft transected and tapered from 16 mm to 8 mm in diameter...

The use of continuous-flow left ventricular assist devices (CF-LVADs) has revolutionized the landscape of mechanical circulatory support for patients with heart failure. Clinical trials are already testing the next generation of CF-LVADs. In this study, our objective was to review our long-term experience with the current generation of CF-LVADs, specifically, the HeartMate (HM) II (Thoratec Corp, Pleasanton, CA). In this single-center retrospective analysis, we evaluated the records of 278 consecutive patients who underwent a total of 302 HM II placements from June 2005 through June 2014...

With more than 60 years of continuous development and improvement, a variety of temporary mechanical circulatory support (MCS) devices and implantation strategies exist, each with unique advantages and disadvantages. A thorough understanding of each available device is essential for optimizing patient outcomes in a fiscally responsible manner. In this state of the art review we examine the entire range of commonly available peripheral and centrally cannulated temporary MCS devices, including intra-aortic balloon pumps, the Impella (Abiomed, Danvers, MA) family of microaxial pumps, the TandemHeart (CardiacAssist Inc, Pittsburg, PA) pump and percutaneous cannulas, centrally cannulated centrifugal pumps such as the CentriMag (Thoratec Corp, Pleasanton, CA/St Jude Medical, St Paul, MN/Abbott Laboratories, Abbott Park, IL) and Rotaflow (Maquet Holding BV & Co KG, Rastatt Germany), and extracorporeal membrane oxygenation...

Continuous flow ventricular assist devices (cfVADs) provide a life-saving therapy for severe heart failure. However, in recent years, the incidence of device-related thrombosis (resulting in stroke, device-exchange surgery or premature death) has been increasing dramatically, which has alarmed both the medical community and the FDA. The objective of this study was to gain improved understanding of the initiation and progression of thrombosis in one of the most commonly used cfVADs, the Thoratec HeartMate II...

Background Left ventricular assist devices (LVADs) have revolutionized the treatment of patients with end-stage heart failure. These devices are replaced when pump complications arise if heart transplant is not possible. We present our experience with HeartMate II (HMII (Thoratec, Plesanton, California, United States)) LVAD pump exchange. Materials and Methods We retrospectively reviewed all cases that required pump exchange due to LVAD complication from November 2011 until June 2016 at a single high-volume institution...